Clinical Research Associate Trainee
- Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
- Gain experience in study procedures by working with experienced clinical staff in Clinical Research Associate (CRA), Clinical Research Specialist (CRS) and Clinical Trials Assist (CTA) roles. May also work collaboratively with other functional groups such as Data Management and Pharmacovigilance.
- Under close supervision, perform site selection, initiation, monitoring and close out visits in accordance with contracted scope of work and good clinical practices.
- Under close supervision, administer protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
- Under close supervision, evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Project Manager (CPM), CRS and/or line manager.
- Under close supervision, manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution.
- Under close supervision, create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
- Degree or currently enrolled in bachelor’s degree program in health care or other related discipline; or equivalent combination of education, training and experience
- Awareness of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
- Good written and verbal communication skills including good command of English language
- Basic organizational and problem-solving skills
- Working time management skills
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
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